The present invention enables the endoscopic treatment of organs. It can be used to manipulate the wall of a hollow organ, and to fixate two or more regions of the wall of the hollow organ to each other. An example of a hollow organ for which this invention applies is the stomach. This invention is applicable to any procedure in which regions of the stomach are manipulated and affixed to one another. This invention is particularly useful for procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated. Numerous procedures are enabled by this invention, for example procedures to treat gastroesophageal reflux disease (GERD) or procedures to treat obesity. A specific example of a GERD procedure which is enabled by this invention is plication of the stomach wall. Specific examples of obesity procedures which are enabled by this invention include stomach bypass or Roux-en-Y procedures, and stomach volume reduction procedures. The use of this invention to treat GERD will be used as an illustrative example.
The historical progression of the refinement of GERD treatment has been towards less invasive procedures. Open surgery, such as Nissen Fundoplication, was the treatment of choice for many years. Open surgery provides the advantages of allowing large areas of stomach tissue to be easily manipulated, providing access to the external wall of the stomach (serosa), and providing direct manipulation of tissues with the surgeon's hands and instruments. Disadvantages of open surgery include the risks associated with general anesthesia, the time required to gain access to the operative site, blood loss, the time required to close the tissues which were cut or dissected to obtain access to the operative site, post-operative pain, post-operative infection, lengthy post-operative recovery period, post-surgical adhesions, and cosmetic scarring due to large abdominal incisions. Additionally, risks of blood clots, pulmonary embolus, dehiscence, and pain are associated with open surgery.
Laparoscopic surgery, such as laparoscopic Nissen fundoplication, was next developed and popularized. Laparoscopic surgery provides the advantages of excellent, close-up visualization of tissues, fewer and smaller post-operative adhesions as compared to open surgery, and smaller cosmetic scarring. Laparoscopic surgery has the disadvantages of requiring a high degree of skill and training by the surgeon, and requiring specialized and expensive equipment.
Endoscopic procedures for the treatment of GERD were then developed. Examples of endoscopic GERD treatments can be seen in U.S. Pat. No. 6,663,639, Laufer, et al; U.S. Pat. No. 5,792,153 Swain et al. U.S. Pat. No. 6,254,598 Edwards, et al. U.S. Pat. No. 6,113,609 Adams; and U.S. Pat. No. 6,238,335 Silverman, et al. as well as a published article on Endogastric Solutions, Minimally Invasive Therapy, 2006, 15:6; 348-355. Endoscopic GERD treatments provide the advantages of less post-procedure pain and faster post-procedure recovery as compared to either open or laparoscopic surgical procedures, fewer post-procedure adhesions, no external scarring and the possibility of performing the procedure with the patient under sedation rather than general anesthesia. Disadvantages of endoscopic GERD treatment include lower efficacy as compared to open or laparoscopic surgical procedures, safety concerns during the procedures, and the complexity of the devices that are required to manipulate the tissue endoscopically.
Endoscopic procedures for the treatment of GERD can be separated into three categories. This first is procedures that modify tissue (e.g. U.S. Pat. No. 6,254,598 Edwards, et al). These procedures modify the tissue by applying energy, for example radiofrequency energy. Safety concerns with these procedures have led to discontinuation of their use in treating GERD.
The second category of endoscopic GERD treatment procedures is procedures that reshape tissue by adding foreign material (e.g. U.S. Pat. No. 6,238,335 Silverman, et al). These procedures introduce a foreign material, such as a polymer or collagen, into the tissue. A significant disadvantage of these procedures is that the physician cannot visualize the material as it is being implanted, and thus is not sure where in the body it is ending up. For example, the material may inadvertently be injected into the lumen of the aorta, which can result in death. The material may also migrate after implantation. These concerns have led to discontinuation of these procedures for the treatment of GERD.
The third category of endoscopic GERD treatment procedures is procedures that manipulate tissue to bring multiple regions of tissue together and fixate the tissue. These procedures are of two types. The first type of procedure that manipulates tissue to bring multiple regions of tissue together and fixate the tissue are procedures in which multiple regions of the inner surface of the stomach are brought into apposition and fixated. The device presented in (U.S. Pat. No. 5,792,153 Swain et al) has been used for this type of procedure. The stomach is lined with mucosal tissue, which has a low likelihood of healing to itself. Thus a disadvantage of this type of procedure is that often the tissue does not heal (i.e. mucosal-to-mucosal tissue apposition often does not heal). When the tissue does not heal it is less likely to remain in apposition over time, and thus the treatment is temporary and is not effective in treating GERD. The second type of procedure that manipulates tissue to bring multiple regions of tissue together and fixate the tissue are procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated. The devices presented in (U.S. Pat. No. 6,663,639, Laufer, et al) and (Minimally Invasive Therapy, 2006, 15:6; 348-355) have been used for this type of procedure. The outer surface of the stomach is serosal tissue, which does tend to heal to itself (i.e. serosal-to-serosal apposition does tend to heal). Thus an advantage of this type of procedure is that the multiple regions of the outer surface of the stomach that are brought into apposition will heal to one another, and the treatment is permanent and thus is effective in treating GERD for a long period of time.
Thus to date the procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated have been the most effective endoscopic treatments for GERD. The devices which currently exist for use in procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated present several disadvantages, however.
The first disadvantage of the devices which currently exist for use in procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated is that the devices must apply high loads in order to bring the regions of tissue into apposition. This is because the devices must apply the loads in a direction that is at an angle from the central axis of the shaft of the device. This geometry dictates that the devices have complex mechanisms, usually with hinged components. High loads must be applied near the base of the hinged components to obtain enough load at the distal end of the hinged components to manipulate the tissue sufficiently to bring multiple regions into apposition. Thus the mechanisms that actuate the hinged components are complex, expensive, and potentially unreliable.
The second disadvantage of the devices which currently exist for use in procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated is that the complexity and expense of the devices dictates that the only practical way to enable them is as reusable devices. Reusable devices such as these must be cleaned and disinfected in between uses, and present the risk of cross-contamination from one patient to another. Disinfection also requires that the devices be sealed to prevent cleaning and disinfecting solutions from damaging the complex mechanisms, further increasing the cost of the devices and decreasing their reliability.
The third disadvantage of the devices which currently exist for use in procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated is that the devices are large. This is due to the space required for the mechanisms discussed above. The large size of the devices, particularly the large cross-sectional areas, makes advancement through the esophagus difficult, which can increase patient discomfort, cause esophageal trauma or perforation and/or cause respiratory problems.
The fourth disadvantage of the devices which currently exist for use in procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated is that device malfunction may require surgical intervention to allow removal of the device from the patient. If the actuating mechanism malfunctions when the device is engaged with the tissue, the device can become locked onto the stomach with no way to remove it endoscopically. In such an instance emergency surgical intervention is required to disengage the device from the tissue and remove the device from the patient. This puts the patient at risk for any of the complications normally associated with surgery, such as infection, pain, post-surgical adhesions, scarring, general anesthesia risk, and other generally known risks.
The fifth disadvantage of the devices which currently exist for use in procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated is that the geometry of engaged regions of the stomach is limited, both in terms of location in the stomach, and in distance from each other, by the device geometry. Regions of the tissue that are brought together can only be regions that can be accessed by the portions of the device that engage tissue. The further apart from each other these regions are, the greater the mechanical challenge that the device must overcome in order to bring the regions into apposition.
The sixth disadvantage of the devices which currently exist for use in procedures in which multiple regions of the outer surface of the stomach are brought into apposition and fixated is that there is no way to ensure that structures outside of the stomach are not involved in the fixated tissue.
Thus, the ideal endoscopic procedure for the treatment of GERD will combine the advantages of open, laparoscopic and endoscopic treatments, without any of the disadvantages of these treatments. Specifically, the ideal endoscopic procedure for the treatment of GERD will:
allow large areas of stomach tissue to be easily manipulated;
allow access to the external wall of the stomach (serosa);
result in no cosmetic scarring;
minimize post-operative adhesions;
minimize post-procedure pain;
enable fast post-procedure recovery;
allow the possibility of performing the procedure with the patient under sedation rather than general anesthesia;
bring multiple regions of the outer surface of the stomach into apposition;
provide a high degree of efficacy;
not require loads to be applied at an angle from the central axis of the device;
utilize an apparatus which does not lock onto the tissue at any point during the procedure;
not require surgical intervention in the event of a device malfunction;
be possible with simple, inexpensive, disposable equipment;
be possible with devices that do not require hinged components;
be possible with devices that have a high degree of reliability;
be possible with devices that have a small cross-sectional area;
not limit the location of the points of engagement with the tissue;
allow points of tissue that are far from each other to be engaged and brought into apposition; and
ensure that structures outside of the stomach are not involved in the tissue engagement or fixation.
The invention presented herein satisfies these goals, and enables a new, novel, simple, safe and effective method for treating GERD. This invention may also treat other conditions in the stomach or elsewhere in the digestive tract, such as the small or large intestines, or the gall bladder. This invention may also be used to engage and fixation regions of multiple organs to each other, such as the small intestine to the stomach, for example. This invention may also have application in other hollow organs, such as for example the urinary bladder, heart or lungs.